Effectiveness of Using 3D Printed Models to Educate Otolaryngology (Ear, Nose, Nose and Throat (ENT)) Patients About Surgery: A Survey

Pathological Conditions, Anatomical Clinical Trial

Official title:

The Effectiveness of Using 3D Printed Anatomically Accurate Models to Educate Patients About Surgery: A Survey

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02905344
• Other study ID #: 14-07-1962
• Status: Completed
• Phase: N/A
• First received: September 8, 2016
• Last updated: September 13, 2016
• Start date: February 2015
• Est. completion date: November 2015

Study information

• Verified date: September 2016
• Source: University of Notre Dame
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

Within the Ear, Nose, and Throat (ENT) medical space, a relatively small number of patients follow through with elective surgeries to fix ailments like a deviated septum or occluded sinus passage. Patient understanding of their diagnosis and treatment plan is integral to compliance, which ultimately yields improved medical outcomes and better quality of life. Here the investigators report the usage of advanced inkjet 3D printing methods to develop a multimaterial replica of the patient's nasal sinus anatomy, derived from clinical X-ray Computed Tomography (CT) data. The final patient education model was developed over several iterations to optimize material properties, anatomical accuracy and overall display. A two arm, single center, randomized, prospective study was then performed in which 50 ENT surgical candidates (and an associated control group, n = 50) were given an explanation of their anatomy, disease state, and treatment options using the education model as an aid. Each patient was then surveyed for their self-rated understanding of their anatomy, disease, and treatment options.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male and female subjects that are 18 years or older.

• Surgeon must have recommended nasal or sinus surgery

• Not excluded as a surgical candidate

Exclusion Criteria:

• Patients who or not able to read or understand English

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Deviated Nasal Septum
• Pathological Conditions, Anatomical

Locations

Country	Name	City	State
United States	Michiana ENT Specialty Center	South Bend	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
University of Notre Dame

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Question: How did the doctor's visualization help you in your understanding of the surgery?		1 year	No